NCT02663427

Brief Summary

The purpose of this study is to determine whether detection of pepsinogen Ⅰand Ⅱ combined with Helicobacter pylori antibody, so-called ABC method , is fit on gastric cancer screening in community of Wuxi City.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

2 years

First QC Date

January 17, 2016

Last Update Submit

January 25, 2016

Conditions

Stomach Neoplasms

Keywords

pepsinogen Ⅰpepsinogen Ⅱgastric cancer screeninghelicobacter pylorigastrin

Outcome Measures

Primary Outcomes (1)

  • detection rate of gastric cancer among all group

    through study completion, an average of 1 year

Study Arms (4)

PG(-) and Hp(-) Group

EXPERIMENTAL

PG negative （pepsinogen（PG）Ⅰ \> 70ng/ml or PGⅠ/PGⅡ \>7.0）and Hp (helicobacter pylori) negative. A questionnaire survey are accomplished in 40-70 years old candidates. Eligible subjects are detected PG I and II, Hp-IgG antibody through serological examination. Gastroscope also accomplished in all participants.

Device: serological examination and gastroscope

PG(-) and Hp(+) Group

EXPERIMENTAL

PG negative and Hp positive. A questionnaire survey are accomplished in 40-70 years old candidates. Eligible subjects are detected PG I and II, Hp-IgG antibody through serological examination. Gastroscope also accomplished in all participants.

Device: serological examination and gastroscope

PG(+) and Hp(-) Group

EXPERIMENTAL

PG positive (PGⅠ ≤ 70ng/ml and PGⅠ/PGⅡ≤7.0) and Hp negative. A questionnaire survey are accomplished in 40-70 years old candidates. Eligible subjects are detected PG I and II, Hp-IgG antibody through serological examination. Gastroscope also accomplished in all participants.

Device: serological examination and gastroscope

PG(+) and Hp(+) Group

EXPERIMENTAL

PG positive and Hp positive. A questionnaire survey are accomplished in 40-70 years old candidates. Eligible subjects are detected PG I and II, Hp-IgG antibody through serological examination. Gastroscope also accomplished in all participants.

Device: serological examination and gastroscope

Interventions

serological examination and gastroscopeDEVICE
PG(+) and Hp(+) GroupPG(+) and Hp(-) GroupPG(-) and Hp(+) GroupPG(-) and Hp(-) Group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40-70 years old, men and women are not limited, and there are one of the following:
  • Hp infected.
  • Previously suffering from chronic atrophic gastritis, gastric ulcer, gastric polyps, hypertrophic gastritis, pernicious anemia and other precancerous diseases of the stomach.
  • First degree relatives of patients with gastric cancer.
  • Other risk factors for gastric cancer. (high salt, salted diet, smoking, heavy drinking, etc.)

You may not qualify if:

  • Severe heart, liver, kidney, dysfunction or mental disorders
  • History of gastric surgery (including surgery, minimally invasive EMR, ESD)
  • Use of PPI, acid preparation, stomach protecting agent in the first two weeks
  • The researchers considered inappropriate participants.
  • Informed consent cannot be attained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Gastroscopes

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Endoscopes, GastrointestinalEndoscopesDiagnostic EquipmentEquipment and SuppliesSurgical Equipment

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2016

First Posted

January 26, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2018

Study Completion

June 1, 2018

Last Updated

January 26, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will share